The Food and Medication Administration ‘s announcement a week ago that it will no longer review COVID Crisis Use Authorization submissions for laboratory-developed tests has created new uncertainty intended for laboratories amidst an already turbulent environment.
The particular agency’s decision increases questions around reimbursement and legal responsibility protections for those tests moving forward. It might also impact the ability of new laboratory developed tests to compete on the market. That’s because an EUA, that the new LDTs won’t have, are noticed by many clinicians and payors being a mark of quality.
Timothy Stenzel, director from the Office of In Vitro Analysis and Radiological Health at FDA’s Center for Devices and Radiological Health, announced the policy alter during a virtual town hall program on Oct. 7. He stated that the decision to stop review LDTs with regard to EUA was informed by the change in the agency’s priorities toward critiquing EUA requests for tests such as point-of-care and home-based assays which could allow for higher-throughput and more widely dispersed COVID testing. Additionally , Stenzel stated that HHS’ recent determination that FOOD AND DRUG ADMINISTRATION cannot not require premarket overview of laboratory-developed tests without notice and remark rulemaking influenced the agency’s choice to stop review LDTs for EUA.
During a web conferencing hosted last week by 360Dx, At the Hillebrenner, associate director for medical and regulatory programs at FDA’s CDRH, expanded on Stenzel’s remarks.
“The HHS statement indicates that FDA power can only be exercised for these medical tests following a lengthy notice and remark rulemaking process, which is not possible address the current public health require, ” she said. She additional that this notice and comment rulemaking requirement meant the agency “may not be able to remove a badly performing LDT from the market or even take other necessary steps to ensure that these tests for COVID-19 are usually accurate, safe, and reliable. And we need to focus our efforts exactly where we can do that. ”
Like Stenzel, Hillebrenner recommended that the agency’s priorities were moving to focus more on tests that could considerably boost the nation’s testing capacity.
“We’re in a various phase of the pandemic now exactly where we have many authorized tests, inch she said, noting that FOOD AND DRUG ADMINISTRATION has given EUA to a lot more than 275 COVID tests at this point. “We are instead focusing our assets on the tests that increase gain access to, those that have home collection or that you can do at the point or care or even [are] for home use… or tests that significantly raise capacity, those that are high-throughput plus distributed or reduce reliance upon test supplies. ”
This position perhaps makes sense because of the HHS decision and FDA’s limited capacity to review EUA distribution, but it presents a number of questions designed for labs looking to develop COVID laboratory developed tests going forward.
The American Clinical Lab Association was generally supportive from the HHS move but was critical associated with FDA’s decision to stop reviewing SAR-CoV-2 LDTS.
“Many of the tests that have been granted EUAs for COVID-19 testing are revolutionary, high-throughput LDTs that have reduced dependence on supplies and been essential to expanding testing capacity, inch ACLA President Julie Khani mentioned in a statement last week. “These are usually exactly the kinds of tests that FOOD AND DRUG ADMINISTRATION has stated it wants to prioritize. ACLA believes the FDA ought to continue to allow labs to under your own accord submit EUAs for FDA evaluation and authorization. Today’s announcement by FDA creates unnecessary confusion. inch
One part of confusion is how, or in the event that, labs will be able to obtain liability safety for their tests. Typically, the Public Preparedness and Emergency Preparedness (PREP) Work gives test providers immunity through liability claims stemming from the usage of tests (or other disease countermeasures) during a public health emergency. Nevertheless , the PREP Act provides this particular protection only for tests that have obtained EUA.
This implies new SARS-CoV-2 LDTs won’t possess any statutory liability protection, mentioned Jeff Gibbs, a director in the law firm Hyman, Phelps & McNamara, who formerly served as FDA’s associate general counsel for observance. He said that while labs do generally consider liability to be a main concern impacting their decisions whether to offer LDTs, the SARS-CoV-2 circumstance could prove different.
“Labs are developing these types of tests much faster than perhaps they will, otherwise, and they are being used in different kinds of methods, and you can imagine scenarios where the dangers are quite different from what they are accustomed to, inch Gibbs said. “Normally, LDTs are usually developed and commercialized over a lengthier time frame, so there could be risk aspects here that you would not normally have. inch
This fits observations from others in the field. For example, in May, Gregory Tsongalis, a teacher of pathology and laboratory medication, and director of clinical genomics and advanced technology at Dartmouth College’s Geisel School of Medicine, stated when recounting his lab’s initiatives to develop a SARS-CoV-2 LDT which he had been concerned that FDA’s EUA standards had been too lax plus noted that they were considerably much less rigorous than the standards his laboratory typically used for validating LDTs.
Gibbs said that it really is unclear “what is going to happen within the product liability world once the turmoil calms down. ”
“Lawyers are always looking for ways to prosecute, ” he said, noting which the first wave of COVID-19-related legal cases has largely focused on employers along with, for instance, workers claiming that companies have not complied with workplace safety regulations.
Gibbs said it was hard to say when there would be a later wave associated with lawsuits around erroneous test outcomes, but he suggested it could be a reason for concern for labs.
Reimbursement could also be a problem. Under the Family First Coronavirus Action (FFCRA), most commercial payors should cover medically necessary SARS-CoV-2 assessment without cost sharing, prior consent or other medical management needs, and requires payors to cover tests by out-of-network labs.
These requirements only protect tests with EUA, however , which usually raises the question of whether labs developing new SARS-CoV-2 LDTs can struggle to get reimbursed for their checks since they will not be able to get EUA.
“It’s a critical question, ” said Robert Boorstein, medical director at Brooklyn-based Lenco Diagnostic Laboratories.
He added that beyond possible reimbursement struggles, new tests may likely face difficulties getting clinicians for their services without EUA.
“A lot of people look for FOOD AND DRUG ADMINISTRATION approval as a mark of high quality, ” he said. “And in case you eliminate the FDA from that, then you definitely are dependent on the LDT procedure, which some of the stakeholders may not actually respect. ”
Boorstein said that a number of his lab’s clients had only wanted to make use of assays with EUA for examining.
He mentioned that many reference labs have varied SARS-CoV-2 offerings that would allow them in order to shuffle between EUA and non-EUA tests as customers demand. Nevertheless , he said that the FDA choice could present a challenge to labs that have not traditionally done contagious disease testing but are now establishing SARS-CoV-2 testing to support their companies during the pandemic.
For instance, Myriad Genetics, which has been strike hard by the pandemic, said recording that it was developing a SARS-CoV-2 molecular check for which it planned to seek EUA. It is unclear, however , whether the corporation managed to received authorization prior to the FDA’s announcement last week. A Myriad spokesperson declined to comment.
Gibbs agreed that the unavailability of the EUA pathway will make this more difficult for companies developing brand new LDTs to compete with those testing with EUAs. He added that this FDA move could also impact the capability of labs to make modifications in order to existing LDTs.
“Different companies are at different levels, ” he said. “Companies which have LDTs that were under review simply by FDA, they are committed to this process. They might [now] be in a competitive disadvantage, but I suppose many of those companies will go ahead and provide the test having developed it plus made it ready to be commercialized. inch
“Other businesses that are just beginning the process might look at this, see how many LDTs already are out there, look at how many there are along with EUAs, and say, can we compete. ” he said.
Boorstein said that whilst, in theory, other bodies could take on the gap left by FOOD AND DRUG ADMINISTRATION to provide a mark of test high quality, these organizations lack the band width to serve this role. For example, he noted that New York California’s stringent clinical testing requirements can provide customers confidence that medical tests having gone through this approval procedure are up to standard.
“But if everyone chooses to go through New York, that is just likely to bury New York and slow the procedure down, ” he said.
Boorstein said he or she believed that accreditation agencies such as the College of American Pathologists which are responsible for ensuring that laboratories meet the CLIA standards required for facilities to offer LDTs also lack the capacity to provide well-timed oversight of SARS-CoV-2 LDTs.
CMS is in charge of enforcing CLIA regulations, and last week the particular agency announced that it had released 171 cease-and-desist letters to laboratories that were offering SARS-CoV-2 LDTs with out proper CLIA certifications in place. Inside a statement, CMS said the words “ordered these laboratories to stop instantly to safeguard the integrity of COVID-19 testing, and protect patients through potential endangerment if provided incorrect or unreliable test results. inch Though CMS did not explicitly tie up its announcement to FDA’s LDT decision, its timing suggests the particular agency may be trying to reassure customers about the quality of SARS-CoV-2 lab tests offered as LDTs.
On a related note, Hillebrenner’s comments during the webinar shed some light within the status of home collection gadgets, which has been an outstanding question since the HHS announcement. Many observers have thought that FDA would consider the unit part of the larger LDTs for which these were used and, as such, exempt through premarket regulation by the agency without warning and comment rulemaking.
During the webinar, however , Hillebrenner said that “tests that are run along with home-collected specimens… are not considered LDTs, ” and that the agency may still review these tests regarding EUA if labs make a submitting.
This particular story first appeared in our sister syndication, 360Dx , which provides in-depth insurance of in vitro diagnostics as well as the clinical lab market.